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一个临床Trial Agreement (CTA) is an agreement between UTHealth and an Industry sponsor (typically a pharmaceutical or device company) to conduct a clinical study in which the protocol iswritten and provided由行业赞助商。

*注意 - 如果该协议是关于Uthealth教师编写的协议，或者是作为Uthealth教职员工与行业赞助商之间的合作而写的赞助研究协议beplay苹果手机能用吗是必须的。看临床试验- PI Initiated想要查询更多的信息。

过程

如果行业赞助商与UTHealth医师/PI联系以参与研究，则PI和部门管理员应进行可行性评估，以确定参加临床研究是否在经济上和操作上是可行的。

如果已确定PI/部门希望参加，则PI或指定人员应提交合同以协商协议的法律条款。

The Proposal Development (PD) module is used in conjunction with the Agreement (AGT) module to submit Clinical Trial Agreements to SPA for processing. Each Clinical Trial Agreement must have a Proposal record and an Agreement record in START. (These records are linked in START.)

    • The Agreement module is used for: Submitting the Agreement itself to SPA for review and tracking the status of negotiations of legal terms.
      • The Proposal module is used for: Submitting Project information to SPA for project and budget review and approval, regulatory approvals, and financial account set up.

*看“Contract/ Coverage Analysis/ Proposal Record Workflow Document“for a visual overview of the process under “Tools and Resources/” Forms and Templates” within the Clinical Research Finance section.

部门任务/责任

1. Conduct a Feasibility assessment

2.提交给Spa的新开始协议记录。通过创建新协议记录，通过开始提交合同。（选择类型“临床试验协议”）请参阅开始指导文件“临床试验-PD

  • Complete Agreement Information Form
  • 上传发起人提供的协议草案副本
  • Upload a copy of Protocol

3.将协议提交给IRB

  • This initiates the coverage analysis build process in SPA.

4. Submit a new Proposal Development (PD) Record to SPA for budget review and approval after the following have been completed:

  • Billing Coverage analysis has been completed (SPA staff or START will send notification once completed CA is uploaded into START)
  • 内部预算已经完成（see CAIB tool guidance document under tools and forms Clinical Research Finance）
  • PI/研究团队已经完成了与赞助商的预算谈判。

5. Upload required documents. The PD record must be completed accurately and data entered into all tabs. The following documents must be uploaded under the attachments tab:

  • 赞助商的最终预算副本
  • 带有完整内部预算信息的CAIB工具的副本
  • Copy of IRB approval(s)
  • RCOI表格为R＆A表格中列为研究团队成员的每个人签名

水疗任务/职责

Negotiate legal terms of the agreement with sponsor on behalf of the PI and the University.Note To ensure SPA’s efforts are s in line with department priority, SPA prioritizes agreements in which the Proposal records have been submitted to SPA for budget review.

Ensure a billing coverage analysis is built and uploaded into START. SPA creates a separate Agreement (AGT) record in START for the coverage analysis (linked to the CTA AGT and CTA PD records if available). START will send notification to the Department once the CA AGT record has been completed.

将与PI签名的最终协议路由机构签署者通过Start签名。

在进行机构签名水疗中心之前，将确认以下项目已完成和/或在PD记录下上传：

    • “批准”的覆盖范围分析AGT记录状态
    • 与PI签名的最终协议
    • PD record submitted to SPA (must be signed off by PI and DMO via START automated e sig routing)
    • PD记录准确完成
    • 确保所有必需的文档已在PD记录下上传

提交提案记录（PT）通过开始为研究建立财务帐户以发布奖励。

Post Award Finance team send out award set up notice via email.

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